BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARESCAPE MONITOR B850

    MDR report key: 8424033 · Received March 15, 2019

    Report

    Report Number
    8424033
    Event Type
    Death
    Date Received
    March 15, 2019
    Date of Event
    February 25, 2019
    Report Date
    March 12, 2019
    Manufacturer
    GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
    Product Code
    MHX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    STAFF NOTICED PATIENT'S HEART RATE WAS 20-30 AND ASKED IF THE PATIENT WAS A DO-NOT-RESUSCITATE COMFORT CARE (DNRCC). I OVERHEARD THIS DISCUSSION AND WENT IN TO PATIENT'S ROOM WHERE I FOUND THE PATIENT TO BE IN PULSELESS ELECTRICAL ACTIVITY AND VOMITING AND IMMEDIATELY BEGUN CHEST COMPRESSIONS AND YELLED FOR CODE BLUE TO BE ACTIVATED. STAFF REVIEWED THE HEART RATE ALARM AFTER THE CODE BLUE AND IT APPEARED TO BE ON AND SET TO ALARM IF HEART RATE WENT BELOW 50.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218876 CARESCAPE MONITOR B850 MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) MHX GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. CARESCAPE DI9KT

    Patients

    Seq Age Sex Outcome Treatment
    1 29930 DA Death